使用真实世界的数据进行临床研究:叙述性审查.
Yuya Kimura1, Taisuke Jo2, Hiroki Matsui3
1Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan; Clinical Research Center, NHO Tokyo National Hospital, 3-1-1 Takeoka, Kiyose-shi, Tokyo, 204-8585, Japan.
Respiratory investigation
|August 25, 2024
概括
现实世界数据 (RWD) 研究,特别是使用行政索赔数据库的研究,在随机对照试验 (RCT) 不可行时,提供了有价值的替代方案. 了解不同RWD源的特征对于准确的研究解释至关重要.
科学领域:
- 医疗保健服务研究 医疗服务研究
- 生物统计学 生物统计学
- 流行病学 流行病学
背景情况:
- 随机对照试验 (RCT) 和真实世界数据 (RWD) 研究具有互补的优点和缺点.
- 当RCT不可行时,RWD研究是关键的替代方案.
- 行政索赔数据库是RWD的重要来源.
研究的目的:
- 审查各种类型的RWD研究,重点关注行政索赔数据库.
- 为突出选择特定研究问题的适当RWD来源的重要性.
- 强调读者需要了解RWD数据库的特点,以便正确解释研究结果.
主要方法:
- 使用真实世界的数据进行研究的叙述性综述.
- 检查日本特定类型的行政索赔数据库,包括诊断程序组合 (DPC) 数据库,商业数据库 (JDMC,DeSC) 和国家健康保险索赔和特定健康检查数据库 (NDB).
主要成果:
- 不同的行政索赔数据库在人口,患者环境,变量和可访问性方面具有独特的特点.
- 选择最合适的数据库对于有效解决特定研究问题至关重要.
- 了解数据库特征对于理解研究结果的上下文和局限性至关重要.
结论:
- 机动车研究,特别是那些使用行政索赔数据的研究,是RCT的宝贵补充.
- 研究人员必须根据他们的研究目标仔细选择RWD来源.
- 充分了解RWD数据库属性可以提高研究结果的有效性和可解释性.
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